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1. Advisory Committee on Medicines Scheduling (ACMS #24)
Delegate's final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is not to amend the current Poisons Standard in relation to sildenafil.
Reasons:
The delegate has confirmed that the reasons for the final decision align with the reasons for the interim decision. Additional reasons for the final decision are the following:
- The applicant claims that most patients for whom sexual activity does not represent a cardiac risk can initiate or resume sexual activity and begin ED treatment without further testing or evaluation. However, CVD cannot be diagnosed by a pharmacist, and the list of diagnosis tools (including ECG and other cardiac testing) recommended by the Princeton III Consensus Recommendations for the Management of ED and CVD are not possible in a pharmacy setting[1].
- Although there were proposed education and checklist material included in the application it was not felt that these would mitigate the risks of down scheduling. These did not appear to address:
- Requirements for pharmacists to have written documentation of their consultation, outlining the clinical assessment they undertook and whether they supplied medication or referred.
- Well-developed clinical referral pathways for pharmacists that must be adhered to.
- The pharmacy checklist states "The following has been created as a useful aide-memoire to help determine whether your patient is suitable for XXXXXXXXX, or whether he should be seen by a doctor for further advice. You should use your professional judgement to decide when and how to use this Checklist." This means that it is not seen as having to be used by the pharmacist.
- The checklist also states: "You should consider possible causes of erectile dysfunction, such as undiagnosed depression, anxiety, excessive alcohol use and taking certain medicines." The ability of a pharmacist to diagnose some of these conditions such as undiagnosed depression and anxiety is questioned.
- Based on the information provided, the additional controls proposed for Schedule 3 sildenafil supply were not considered to be sufficient Appendix M criteria for ED and sildenafil treatment given that ED is a symptom of other conditions which require medical practitioner diagnosis, monitoring and treatment.
Public submissions on the interim decision
Two (2) public submissions were received before the second closing date in response to an invitation published on 10 September 2018 under regulation 42ZCZP of the Regulations. Both submissions opposed the interim decision.
The main points provided in opposition of the amendment were:
- Sildenafil meets the S3 criteria rather than those of S4 because erectile dysfunction is a self-recognised/self-diagnosed condition.
- During the Scheduling Stakeholder Forum held 6 March 2018 TGA used sildenafil as a case study to facilitate discussions on Appendix M. It was surprising, then, that the Record of Reason included the statement that 'Appendix M is not appropriate for ED and sildenafil treatment given that ED is a symptom of other conditions which require medical practitioner diagnosis, monitoring and treatment.' Appendix M is appropriate for ED and sildenafil. The submission claims that additional controls for Schedule 3 sildenafil that could be incorporated in Appendix M would ensure safe and appropriate supply of the product.
- The record of reasons should revise the statement saying no education or checklist material was provided in the submission, as this is not accurate.
- Request: the statement regarding down scheduling being not an appropriate mechanism to address counterfeit sildenafil be removed, as this was not claimed in the application.
- Data provided was not taken into account that men are being prescribed in most cases a PDE5 inhibitor in the current primary care setting without additional diagnostic testing of the underlying cause
- The Delegate cited the diagnosis tools for risk factors of ED in the Princeton III Consensus but failed to mention its recommendation that most patients for whom sexual activity does not represent a cardiac risk can initiate or resume sexual activity and begin ED treatment without further testing or evaluation.
- It is unclear why the safety profile of sildenafil is still considered a concern given robust evidence was provided.
- The Delegate noted that the limited pack size does not address risk to consumers; however, the proposed labelling included the appropriate warnings that would facilitate correct and safe use of the medicine, rather than simply being limited to pack size.
- Too little emphasis on the potential benefits of re-scheduling were placed by the ACMS and the Delegate and they dismissed the recent and relevant decisions made by comparable overseas regulatory authorities on the public health benefit of increased access.
Interim decision
The interim decision for sildenafil was published on the TGA website on 10 September 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACMS, September 2018 – 1.1 Sildenafil.
Scheduling proposal
The pre-meeting scheduling proposal for sildenafil was published on the TGA website on 10 April 2018 at Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS.
Footnotes
| [1] | Nehra et al. (2012) 'The Princeton III Consensus Recommendations for the Management of Erectile Dysfunction and Cardiovascular Disease', Mayo Clin Proc, 87(8), 766-778 |
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